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Bimatoprost
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- Active ingredient
- Bimatoprost 0.3 mg/1 mL
- Other brand names
- Bimatoprost (by Akorn)
- Bimatoprost (by Akorn)
- Bimatoprost (by Alembic Pharmaceuticals Inc.)
- Bimatoprost (by Alembic Pharmaceuticals Limited)
- Bimatoprost (by Alembic Pharmaceuticals Limited)
- Bimatoprost (by Amneal Pharmaceuticals Ny Llc)
- Bimatoprost (by Apotex Corp.)
- Bimatoprost (by Aurobindo Pharma Limited)
- Bimatoprost (by Fosun Pharma Usa Inc.)
- Bimatoprost (by Gland Pharma Limited)
- Bimatoprost (by Micro Labs Limited)
- Bimatoprost (by Sandoz Inc)
- Bimatoprost (by Somerset Therapeutics, Llc)
- Durysta (by Allergan, Inc.)
- Latisse (by Allergan, Inc.)
- Lumigan (by Allergan, Inc.)
- Lumigan (by Allergan, Inc.)
- View full label-group details →
- Drug class
- Prostaglandin Analog
- Dosage form
- Solution/ Drops
- Route
- Ophthalmic
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2019
- Label revision date
- December 4, 2025
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Bimatoprost 0.3 mg/1 mL
- Other brand names
- Bimatoprost (by Akorn)
- Bimatoprost (by Akorn)
- Bimatoprost (by Alembic Pharmaceuticals Inc.)
- Bimatoprost (by Alembic Pharmaceuticals Limited)
- Bimatoprost (by Alembic Pharmaceuticals Limited)
- Bimatoprost (by Amneal Pharmaceuticals Ny Llc)
- Bimatoprost (by Apotex Corp.)
- Bimatoprost (by Aurobindo Pharma Limited)
- Bimatoprost (by Fosun Pharma Usa Inc.)
- Bimatoprost (by Gland Pharma Limited)
- Bimatoprost (by Micro Labs Limited)
- Bimatoprost (by Sandoz Inc)
- Bimatoprost (by Somerset Therapeutics, Llc)
- Durysta (by Allergan, Inc.)
- Latisse (by Allergan, Inc.)
- Lumigan (by Allergan, Inc.)
- Lumigan (by Allergan, Inc.)
- View full label-group details →
- Drug class
- Prostaglandin Analog
- Dosage form
- Solution/ Drops
- Route
- Ophthalmic
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2019
- Label revision date
- December 4, 2025
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Registration number
- ANDA210263
- NDC root
- 62332-507
- FDA Insert
- Prescribing information, PDF file
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If you are a consumer or patient please visit this version.
Drug Overview
Bimatoprost ophthalmic solution, 0.03% is a synthetic medication designed to help lower elevated intraocular pressure (IOP) in individuals with open-angle glaucoma or ocular hypertension. It works by mimicking the effects of natural substances called prostamides, which help to increase the outflow of fluid from the eye, thereby reducing pressure.
This clear, sterile solution is applied directly to the eye and is effective in managing conditions that can lead to optic nerve damage and vision loss. By lowering IOP, Bimatoprost plays a crucial role in protecting your eyesight and maintaining eye health.
Uses
Bimatoprost ophthalmic solution, 0.03%, is used to help lower high eye pressure in people who have open-angle glaucoma or ocular hypertension. By reducing this pressure, it can help protect your vision and maintain eye health.
It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. Always consult with your healthcare provider for personalized advice and information regarding your treatment options.
Dosage and Administration
To use this medication, you will need to apply one drop directly into the affected eye or eyes. It's important to do this once daily, and the best time to apply it is in the evening. This routine helps ensure that the medication works effectively to address your condition. Remember to follow this schedule consistently for the best results.
What to Avoid
It's important to be aware of certain situations where you should not use this medication. If you have a hypersensitivity (an extreme allergic reaction) to any component of the drug, you should avoid taking it.
Additionally, this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Be cautious, as using it inappropriately can lead to dependence (a condition where your body becomes reliant on the drug). Always follow your healthcare provider's instructions and do not take this medication if you have any of the contraindications mentioned.
Side Effects
You may experience some side effects while using this medication. The most common reaction is conjunctival hyperemia, which is redness of the eye, occurring in about 45% of users. Additionally, you might notice changes in pigmentation, including darkening of the iris (the colored part of your eye), eyelids, and eyelashes. It's important to know that iris pigmentation is likely to be permanent.
You may also see changes in your eyelashes, such as increased length, thickness, and number of lashes, although these changes are usually reversible. Some individuals may experience hypersensitivity (an allergic reaction), so it's essential to monitor how your body responds to the treatment. If you have any concerns about these side effects, please consult your healthcare provider.
Warnings and Precautions
You should be aware that using this medication may lead to changes in the color of your iris (the colored part of your eye), eyelids, and eyelashes. The change in iris color is likely to be permanent, while changes to your eyelashes, such as increased length, thickness, and number, are usually reversible.
There are no specific laboratory tests required for monitoring while using this medication. If you experience any concerning symptoms or have questions about your treatment, it’s important to reach out to your doctor for guidance.
Overdose
If you suspect an overdose of bimatoprost ophthalmic solution (a medication used for eye conditions), it's important to know that there is no specific information available about overdoses in humans. If an overdose occurs, treatment should focus on relieving symptoms rather than a specific antidote.
In studies with mice and rats, doses much higher than what a child might accidentally ingest did not show any harmful effects. For example, doses up to 100 mg/kg/day were tested, which is significantly more than what a 10 kg child would get from one bottle of the solution. However, if you notice unusual symptoms or have concerns, it’s always best to seek medical advice promptly. If you experience severe symptoms or are unsure, don’t hesitate to contact emergency services for immediate help.
Pregnancy Use
There are currently no well-controlled studies on the use of bimatoprost ophthalmic solution (0.03%) in pregnant women. While postmarketing data suggest that there is no increased risk of major birth defects or miscarriages, animal studies have shown that high doses of bimatoprost can lead to abortion and early delivery in pregnant mice and rats. These adverse effects were not seen at lower doses, indicating that the risk may depend on the amount used.
If you are pregnant or planning to become pregnant, it is important to discuss the use of bimatoprost with your healthcare provider. The potential benefits of using this medication should be carefully weighed against the possible risks to your fetus. Always consult your doctor before starting or continuing any medication during pregnancy.
Lactation Use
If you are breastfeeding and considering the use of bimatoprost ophthalmic solution, 0.03%, it's important to know that it is unclear whether this eye treatment can enter your breast milk in significant amounts. In studies with lactating rats, bimatoprost was found in breast milk at much higher doses than what is typically used in humans, but there is no data on its presence in milk at doses relevant to your treatment.
When deciding to use this medication, weigh the benefits of breastfeeding against your need for bimatoprost and any potential risks to your nursing child. Always consult with your healthcare provider to ensure the best decision for both you and your baby.
Pediatric Use
It is important to be cautious when considering this medication for children under 16 years old. The use of this drug in younger patients is not recommended due to potential safety concerns, particularly the risk of increased pigmentation (darkening of the skin) that may occur with long-term use.
If you are a parent or caregiver, it's best to consult with a healthcare professional to discuss safe treatment options for your child. Always prioritize their health and well-being by seeking expert advice.
Geriatric Use
As an older adult or caregiver, it's reassuring to know that there are no significant differences in safety or effectiveness when using this medication compared to younger adults. This means that the treatment can be just as beneficial for you or your loved one, without added risks that sometimes come with age.
However, it's always important to discuss any specific health concerns or conditions with your healthcare provider, as they can help tailor the treatment to meet your individual needs.
Renal Impairment
It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.
Hepatic Impairment
If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and monitor your liver function as needed.
Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using this medication.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.
Storage and Handling
To ensure the best results with your bimatoprost ophthalmic solution, store it in a cool, dry place at a temperature between 2°C to 25°C (36°F to 77°F). This helps maintain the effectiveness of the solution. Once you open the bottle, you can continue to use it until the expiration date printed on the label, so be sure to check that date before use.
When handling the solution, always wash your hands thoroughly to maintain cleanliness and avoid contamination. This is important for your safety and the effectiveness of the product. If you have any questions about disposal or further handling instructions, consult your healthcare provider for guidance.
Additional Information
You should be aware that treatment with bimatoprost ophthalmic solution may lead to increased pigmentation of your eyes. If you notice any significant changes in the color of your iris, it's important to have regular check-ups with your healthcare provider.
Before using the eye drops, make sure to remove your contact lenses. You can put them back in about 15 minutes after applying the drops.
FAQ
What is Bimatoprost ophthalmic solution, 0.03% used for?
Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
How does Bimatoprost work?
Bimatoprost mimics the effects of naturally occurring substances called prostamides and lowers intraocular pressure by increasing the outflow of aqueous humor through specific routes in the eye.
What are the common side effects of Bimatoprost?
The most common side effect is conjunctival hyperemia (redness of the eye), occurring in about 45% of patients. Other effects include pigmentation changes in the iris and eyelashes.
Can Bimatoprost be used during pregnancy?
Bimatoprost should only be used during pregnancy if the potential benefits justify the risks, as animal studies have shown adverse effects at high doses.
Is Bimatoprost safe for breastfeeding?
It is not known if Bimatoprost is present in human milk, so the benefits of breastfeeding should be weighed against the mother's need for the medication.
How should Bimatoprost be administered?
You should instill one drop in the affected eye(s) once daily in the evening. Remove contact lenses before use and wait 15 minutes before reinserting them.
What precautions should I take while using Bimatoprost?
Be aware of the possibility of increased pigmentation of the iris and eyelashes. Regular eye examinations are recommended if you notice significant changes.
What are the storage conditions for Bimatoprost?
Store Bimatoprost at 2°C to 25°C (36°F to 77°F). After opening, use it until the expiration date on the bottle.
Are there any contraindications for using Bimatoprost?
Yes, Bimatoprost is contraindicated in individuals with hypersensitivity to any of its components.
Can Bimatoprost be used in children?
Bimatoprost is not recommended for use in pediatric patients below the age of 16 due to potential safety concerns.
Packaging Info
The table below lists all NDC Code configurations of Bimatoprost, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Bimatoprost, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Bimatoprost ophthalmic solution, 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-(1E,3S)-3-hydroxy-5-phenyl-1-pentenylcyclopentyl]-5-N-ethylheptenamide. The molecular weight of bimatoprost is 415.58, and its molecular formula is C25H37NO4. Bimatoprost is a powder that is soluble in methanol and alcohol.
The ophthalmic solution is a clear, isotonic, colorless, sterile formulation with an osmolality of approximately 290 mOsmol/kg. It contains bimatoprost as the active ingredient at a concentration of 0.3 mg/mL. Inactive ingredients include benzalkonium chloride at 0.05 mg/mL, disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust the pH, which ranges from 6.8 to 7.8 during its shelf life.
Uses and Indications
Bimatoprost ophthalmic solution, 0.03%, is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
There are no teratogenic or nonteratogenic effects associated with this medication.
Dosage and Administration
The recommended dosage for administration is one drop in the affected eye(s) once daily in the evening. Healthcare professionals should instruct patients to ensure proper technique when administering the drop to maximize efficacy and minimize potential contamination. It is advised to avoid touching the dropper tip to any surface, including the eye, to maintain sterility.
Contraindications
Use of this product is contraindicated in individuals with hypersensitivity to any component of the formulation. Due to the potential for severe allergic reactions, administration in such cases may pose significant health risks.
Warnings and Precautions
Pigmentation of the iris, periorbital tissue (eyelid), and eyelashes may occur with the use of this medication. It is important to note that iris pigmentation is likely to be permanent. Healthcare professionals should inform patients about this potential side effect to ensure they are adequately prepared for any changes.
In addition to pigmentation changes, patients may experience a gradual alteration in their eyelashes, which may include increased length, thickness, and number of lashes. These changes are typically reversible upon discontinuation of the medication. Monitoring for these effects is advisable, and patients should be counseled on what to expect during treatment.
No specific laboratory tests are recommended for monitoring the safety of this medication. However, healthcare providers should remain vigilant for any adverse effects and maintain open communication with patients regarding their treatment experience.
Side Effects
Most patients may experience conjunctival hyperemia, which has been reported in 45% of cases. This is the most common adverse reaction associated with the treatment.
Additionally, pigmentation changes may occur, including pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. It is important to note that iris pigmentation is likely to be permanent.
Patients may also observe gradual changes to their eyelashes, which can include increased length, thickness, and number of lashes. These changes are usually reversible upon discontinuation of the treatment.
Hypersensitivity reactions have been reported, although the frequency of such events is not specified. Careful monitoring for these reactions is advised in patients undergoing treatment.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.
Packaging & NDC
The table below lists all NDC Code configurations of Bimatoprost, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Use in pediatric patients below the age of 16 years is not recommended due to potential safety concerns. Specifically, there is an increased risk of pigmentation changes associated with long-term chronic use in this population. Healthcare professionals should exercise caution when considering treatment options for children and adolescents under 16 years of age.
Geriatric Use
Elderly patients, defined as those aged 65 years and older, have not demonstrated any overall clinical differences in safety or effectiveness compared to younger adult patients. Therefore, no specific dosage adjustments are necessary for this population.
However, it is essential for healthcare providers to remain vigilant when prescribing to geriatric patients, as individual responses may vary. Continuous monitoring for any potential adverse effects or changes in efficacy is recommended to ensure optimal therapeutic outcomes.
Pregnancy
There are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03%, in pregnant women. Postmarketing experience has not indicated an increase in the risk of major birth defects or miscarriages associated with bimatoprost. However, animal studies have demonstrated potential risks. In embryofetal developmental studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses that were at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose, as determined by blood area under the curve (AUC) levels. Notably, these adverse effects were not observed at lower doses, specifically at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended clinical dose.
In pre- and postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis through lactation resulted in reduced gestation length, decreased fetal body weight, increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure at the recommended clinical dose. No adverse effects were noted in rat offspring at exposures estimated at 14 times the human exposure at the recommended clinical dose.
Given that animal reproductive studies may not always predict human responses, bimatoprost ophthalmic solution, 0.03%, should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. The No Observed Adverse Effect Level (NOAEL) for abortion in rats was determined to be 0.3 mg/kg/day, which corresponds to an estimated 47 times the human systemic exposure at the recommended human ophthalmic dose. Similarly, in mice, the NOAEL for abortion and early delivery was 0.1 mg/kg/day, equating to 2.6 times the human systemic exposure at the recommended dose. No abnormalities were observed in rat or mouse fetuses at doses up to 0.6 mg/kg/day.
Healthcare professionals should weigh the potential risks and benefits when considering the use of bimatoprost in pregnant patients.
Lactation
It is not known whether topical ocular treatment with bimatoprost ophthalmic solution, 0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. In animal studies, bimatoprost has been shown to be present in the breast milk of lactating rats at an intravenous dose (i.e., 1 mg/kg) 324 times the recommended human oral dose (on a mg/m² basis); however, no animal data is available at clinically relevant doses.
The developmental and health benefits of breastfeeding should be considered alongside the mother's clinical need for bimatoprost ophthalmic solution, 0.03%, as well as any potential adverse effects on the breastfed child from this treatment.
Renal Impairment
There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
In the event of an overdose with bimatoprost ophthalmic solution, 0.03%, there is currently no available information regarding overdosage in humans. Should an overdose occur, the recommended course of action is to provide symptomatic treatment as necessary.
Toxicity studies conducted in mice and rats via oral administration (by gavage) have demonstrated that doses up to 100 mg/kg/day did not result in any observable toxicity. This threshold is significantly higher—at least 70 times greater—than the potential accidental ingestion of an entire bottle of bimatoprost ophthalmic solution, 0.03%, by a child weighing 10 kg.
Healthcare professionals should remain vigilant for any symptoms that may arise from an overdose and manage them accordingly, although the likelihood of significant toxicity appears to be low based on animal studies.
Nonclinical Toxicology
Bimatoprost was evaluated for its carcinogenic potential in long-term studies conducted in mice and rats. The results indicated that bimatoprost was not carcinogenic when administered via oral gavage for 104 weeks at doses of up to 2 mg/kg/day in mice and 1 mg/kg/day in rats. These doses correspond to at least 192 and 291 times the human systemic exposure at the recommended human dose (RHOD), respectively, based on blood AUC levels.
In terms of mutagenicity, bimatoprost demonstrated no mutagenic or clastogenic effects in several assays, including the Ames test, the mouse lymphoma test, and in vivo mouse micronucleus tests.
Furthermore, bimatoprost did not impair fertility in male or female rats at doses up to 0.6 mg/kg/day, which is at least 103 times the human systemic exposure at the RHOD, based on blood AUC levels.
Postmarketing Experience
No specific postmarketing experience details are available in the provided text. As such, there are no reported adverse events or case reports to summarize.
Patient Counseling
Patients should be informed about the potential for increased brown pigmentation of the iris, which may be permanent. They should also be made aware of the possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution, 0.03%.
It is important to discuss with patients the potential changes in eyelashes and vellus hair in the treated eye during the course of treatment with bimatoprost ophthalmic solution, 0.03%. These changes may lead to differences between the eyes in terms of length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Patients should be reassured that eyelash changes are typically reversible upon discontinuation of treatment.
Healthcare providers should instruct patients to avoid allowing the tip of the dispensing container to come into contact with the eye, surrounding structures, fingers, or any other surface. This precaution is essential to prevent contamination of the solution by common bacteria that can cause ocular infections, which may lead to serious damage to the eye and potential loss of vision.
Patients should be advised to seek immediate medical advice if they develop any intercurrent ocular condition, such as trauma or infection, undergo ocular surgery, or experience any ocular reactions, particularly conjunctivitis and eyelid reactions, regarding the continued use of bimatoprost ophthalmic solution, 0.03%.
Additionally, it is crucial to inform patients that bimatoprost ophthalmic solution, 0.03% contains benzalkonium chloride, which may be absorbed by soft contact lenses. Patients should be instructed to remove their contact lenses prior to instillation of the solution and may reinsert them 15 minutes after administration.
Finally, if patients are using more than one topical ophthalmic drug, they should be advised to administer the drugs at least five (5) minutes apart to ensure proper absorption and effectiveness.
Storage and Handling
Bimatoprost ophthalmic solution, 0.03% is supplied in a container that allows for easy dispensing. It should be stored at a temperature range of 2°C to 25°C (36°F to 77°F) to maintain its efficacy.
Once opened, the solution can be used until the expiration date indicated on the bottle. It is important to ensure that the container is kept tightly closed when not in use to prevent contamination and preserve the integrity of the product.
Additional Clinical Information
Patients receiving treatment with bimatoprost ophthalmic solution, 0.03%, should be informed about the potential for increased pigmentation, particularly in the iris. Regular examinations are recommended for those who notice significant changes in iris pigmentation. Additionally, patients are advised to remove contact lenses before instilling the solution and may reinsert them 15 minutes after administration.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Bimatoprost as submitted by Alembic Pharmaceuticals Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.